Lecture 5 IRB

Obtain Informed Consent

(information, comprehension, voluntary)

Equitable Selection

(no social, racial, sexual, cultural, etc. bias)

Ensure Privacy & Confidentiality

(obtaining & securing data)

Minimize Risks

(physical, psychological, legal, social, economic)

Basic Ethical Principals (3)

1- Respect for Persons: Informed Consent Process 2- Beneficence: Risk/Benefits Assessment (DO NO HARM) 3- Justice: Selection of Research Participants

History: Nuremberg War Tribunal (1947)

Criminal proceedings against German physicians and administrators for willing participation in war crimes against humanity. Horrifying procedures were conducted for "research" purposes on thousands of concentration camp prisoners.

National Research Act (1974) and The Commission's charge was to:

Due to the publicity from the Syphilis Study, the National Research Act of 1974 was passed. The National Research Act created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Commission's charge was to: (1) identify the ethical principles to guide all research involving human subjects and (2) develop guidelines for the conduct of ethical research involving human subjects in accordance with those principles.

Name the ways how rights of the human participant are protected (4)

Equitable Selection Minimize Risks Ensure Privacy and Confidentiality Obtain Informed Consent

Nuremburg Code (1948)

Nazi atrocities in World War II drew attention to the lack of international standards on research with human participants and led to the formulation of the Nuremburg Code (1948).

PURPOSE:

Protect the Rights of Human Participants

Declaration of Helsinki

The Declaration of Helsinki drafted by the world Medical Association in 1964 (most recently updated in 2000) builds on the Nuremberg Code and is the basis for Good Clinical Practices used today.

The National Research Act

The National Research Act (1974) passed primarily in response to the syphilis study, codified the requirement that human participants in research must be protected and set the stage for the issuance of the Belmont Report.

Kefauver Amendment

The thalidomide disaster led to the adoption of the "Kefauver Amendment" (1962) to the Food, Drug and Cosmetic Act, requiring drug manufacturers to prove to the FDA the safety and effectiveness of their products and physicians to obtain informed consent from potential subjects before administering investigational medications.

Thalidomide Use

To establish health and safety standards, Manhattan Project officials authorized studies examining the effects of radiation on humans using hospital patients, pregnant women, mentally disabled children, and enlisted military personnel as subjects. Few of the participants gave informed consent and most had no knowledge that they were being subjected to radioactive materials. Used in the 1950s to combat unpleasant symptoms associated with pregnancy. Patients were not informed that the drug was investigational and still in the testing phase of the regulatory process. After many women were already treated with the drug it was discovered that the drug was teratogenic, causing severe deformities in the fetus. Thalidomide was banned worldwide although ≈12,000 babies were born with severe deformities due to thalidomide.

Syphilis Study in Tuskegee, GA (1932-1972)

Under research conducted by the U.S. Public Health Service, 600 low-income African-American males were infected with syphilis and monitored for 40 years. Participants were not told about their disease and even after a proven cure (penicillin) became available in the 1950s, the study continued until 1972 with participants being denied treatment. Many participants died of syphilis during the study, which was finally stopped in 1973 only after its existence was publicized and it became a political embarrassment.